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German Merck obtains exclusive global development rights for xevinapant
Time of Update: 2021-03-23
Currently in the pivotal Phase 3 TrilynX study, a combination of platinum-containing chemotherapy and standard fractionation intensity-modulated radiotherapy (standard fractionation intensity-modulated radiotherapy) for previously untreated patients with high-risk locally advanced head and neck squamous cell carcinoma (LA SCCHN) .
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8 new drugs approved by the FDA in February 2021
Time of Update: 2021-03-23
Tepmetko (Tepotinib)On February 3, the FDA approved the MET inhibitor tepotinib (trade name: TEPMETKO) developed by EMD Serono, a subsidiary of Merck, Germany through a priority review method for the treatment of jumping mutations in exon 14 (MET ex14) of the MET gene.
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Interpretation | Analysis of Pediatric Drug Varieties and Policy Inventory: EU
Time of Update: 2021-03-22
Part 1: EU legislation and supervision of children's medicationIn 1997, the European Commission discussed the issue of children's medication in an expert round table organized by EMA. The meeting bel
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Candidates whose exams are suspended in 2020 have their passing scores extended by one year
Time of Update: 2021-03-22
An important notice is coming for candidates for licensed pharmacist from the Medical Network on March 10 Candidates who are suspended from taking the exam in 2020 have their passing scores extended
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Xianju Pharmaceutical: Finasteride tablets passed the consistency evaluation of generic drugs
Time of Update: 2021-03-22
Finasteride tablets, specification: 5mg, first obtained US FDA marketing approval in June 1992, with the trade name "PROSCAR".
Finasteride tablets, specification: 1mg, first obtained US FDA marketing approval in December 1997, with the trade name "PROPECIA".
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The top leader of the country said: Will promote the high-quality development of public hospitals!
Time of Update: 2021-03-22
On how to develop high-quality, the top leaders emphasized the following points at the meeting: Improve the social status of medical staff, and severely crack down on medical disturbances and violent medical injuries according to law At the critical moment of the fight against the new crown pneumonia epidemic, the majority of medical workers have lived up to the trust of the party and the people.
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"Zero tolerance" for clinical data issues!
Time of Update: 2021-03-22
Since 2015, the national drug regulatory authority has strictly implemented the "four strictest" spirit and promulgated a number of regulations and policies aimed at strengthening the management of clinical trials of medical devices, focusing on monitoring the authenticity, accuracy, and integrity of clinical trial data to ensure Traceability of the research process.
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When will the net profit of unprofitable pharmaceutical companies such as Junshi and Consino turn positive? Will you be de-marketed?
Time of Update: 2021-03-22
Therefore, similar to Amgen’s leading biotech companies, the early marketization of their products is based on large-scale drugs such as Johnson & Johnson Pharmaceuticals in the United States and Kirin in Japan.
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11 therapies including oligonucleotide drugs and "ready-to-use" T lymphocyte therapy are shortlisted
Time of Update: 2021-03-22
In addition, a number of clinical studies have shown that the infusion of patients' own CD34-positive cells can improve the symptoms of severe limb ischemia.
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Baiyunshan Pharmaceutical Amlodipine Besylate Tablets have passed the quality and efficacy consistency evaluation of generic drugs
Time of Update: 2021-03-22
As of the announcement date, Baiyunshan Pharmaceutical General Factory has invested approximately RMB 4,378,800 in research and development expenses (unaudited) for the consistency evaluation of the drug.
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State Health Insurance Administration: 2020 cumulative settlement of the new crown patient medical expenses of 2.84 billion yuan
Time of Update: 2021-03-22
In terms of epidemic prevention and control, tax reduction and payment delays, in order to reduce the burden on enterprises and support the resumption of work and production, the payment of employee medical insurance units was halved in stages.
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Yuanda Pharmaceutical's anti-tumor drugs are recommended by NICE and approved by FDA for clinical trials
Time of Update: 2021-03-22
In addition, SIR-Spheres® yttrium [90Y] resin microspheres have also recently received FDA approval for clinical trials of primary liver cancer (HCC) to apply for marketing authorization in the United States.
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A hollow capsule company was warned for tampering and fabricating batch records
Time of Update: 2021-03-22
On March 8, the Chongqing Municipal Food and Drug Administration issued an information disclosure form for administrative law enforcement cases. Chongqing Hengsheng Pharmaceutical Capsule Co. , Ltd.
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Merck submits clinical application for TIGIT+Pembrolizumab compound preparation
Time of Update: 2021-03-22
The results of the study show that Vibostolimab monotherapy or combination therapy with KEYTRUDA has manageable safety, and shows anti-tumor activity in patients with PD-1/PD-L1 refractory.
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"Put the tube suit" and deepen it! Quality credit Class A enterprises will be exempt from inspection from March 1
Time of Update: 2021-03-22
Before the announcement, if the application for registration of the second-class product has been accepted and the system verification application has been submitted, but the on-site verification has not been carried out, the system verification application may be withdrawn, and the credit rating certificate and supervision and inspection shall be provided when supplementing the technical review information data.
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[Heavyweight] Chia Tai Tianqing will win the first copy of Lenvatinib
Time of Update: 2021-03-22
Recently, Chia Tai Tianqing Pharmaceutical Group entered the administrative examination and approval stage with generic 4 types of lenvatinib mesylate capsules.
The registration status of lenvatinib mesylate capsules of Zhengda Tianqing Pharmaceutical Group has been changed to "under approval", which is expected to win the first imitation.
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PD-1 new drug PKO/K drug biosimilar drug who will win?
Time of Update: 2021-03-22
For the time being not limited to PD-1, we need to answer a question first, is it a good business to make biosimilar drugs?In recent years, with the expiration of patent protection for multiple “blockbuster”-level original biopharmaceuticals with global sales of more than 1 billion U.
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Novartis anticancer drug Canakinumab Phase III clinical trial failed to reach the primary endpoint
Time of Update: 2021-03-22
CompileriverOn March 9, Novartis announced that the CANOPY-2 Phase III clinical trial of the anticancer drug Canakinumab (ACZ885) did not reach the primary end point of overall survival (OS).
Non-small cell lung cancer stage III The research will continue to evaluate the efficacy of Canakinumab in early treatment.
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Top 10 drugs that lose patent rights in the U.S. market in 2021
Time of Update: 2021-03-22
S. sales in 2020: undisclosed (2019 sales of $600 million)Disease: HypertensionGeneric drugs enter the market: September 17Bystolic, approved for the treatment of high blood pressure, lost the protection of its last patent on December 17 this year.
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Top 10 patent expired drugs in 2021: 3 have entered China involving ranibizumab and sunitinib
Time of Update: 2021-03-22
S. in 2020: Undisclosed ($600 million in sales in 2019)Indications: HypertensionPotential generic drug entry: September 17, 2021When AbbVie signed its Allergan large-scale acquisition plan in 2019, the company tried to consolidate its future after Xiumira.
